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User Guide for patients

CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use.

IMPORTANT USER INFORMATION Review the product instructions before using the Bios device. Instructions can be found in this user manual. Failure to use the Bios device and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in injury associated with misuse of device.

Manufacturer information GraphWear Technologies Inc. 953 Indiana Street, San Francisco CA 94107 Website: www.graphwear.co Email: [email protected]

1 Table of Contents

Safety Statement 4 Indications for use 4 Contraindication 5 No MRI/CT/Diathermy - MR Unsafe 5 Warnings 5 Read user manual 5 Don’t ignore high/low symptoms 5 Don’t use if… 5 Avoid contact with broken skin 5 Inspect 6 Use as directed 6 Check settings 6 Where to wear 6 Precaution 7 Avoid sunscreen and insect repellant 7 Keep transmitter close to display 7 Is It On? 7 Keep dry 8 Application needs to always remain open 8 Device description 8 Purpose of device 8 What’s in the box 8 Operating information 11 Minimum smart device specifications 11 Android 11 iOS 12 Installing the app 12 Setting up Bios devices 32 Setting up Left Wrist (LW) device 32 Setting up Right Wrist (RW) device 42 Setting up Lower Abdomen (LA) device 52

2 Confirming that all devices are connected 64 Removing the devices 65 Removing the sensors 67 How to charge the transmitter 69 Setting up and using your Self Monitoring Blood Glucose (SMBG) meter 78 Inserting blood values into the application 79 Inserting meal and exercise information 85 Inserting medication information 89 Change sensor 92 Providing feedback 98 Troubleshooting information 101 What messages on your transmitter display mean 101 FAQ? 102 I need to access the FAQ from my app 102 I am unable to install the mobile application on my smart device. What should I do? 102 My transmitter is not ON 103 My transmitter will not connect 103 My app notified me that my transmitter has disconnected 103 My transmitter shows ‘Data uploading’ 103 My transmitter shows ‘Open indicate’ 104 What if I lost my phone? 104 My phone ran out of battery 104 What is the QR code on the top left of my app? 104 What is the “?” on the top right of my app? 105 On my Android phone, when I click “Capture”, the app doesn’t take a picture of my SMBG 105 When I wear my devices again and try to connect, the device screen shows a six digit passkey 105 User assistance information 105 Appendix 106 Appendix A - Compatible smart devices 106 Android devices 106 iOS devices 118

3 Safety Statement

What is a Safety Statement

A Safety Statement is a brief statement of the Bios device indications, contraindications (when to avoid using it), relevant warnings, and precautions. The Safety Statements are meant to keep you and the Bios device safe while using it:

1. Indications How, for what purposes, and under what circumstances you should use the Bios device. Indications let you know who should use the Bios device and when.

2. Contraindication Contraindications let you know when not to use the Bios device. If used during these situations, you may hurt yourself or the Bios device and the risk of use clearly outweighs the benefit.

3. Warning Important hazard information: Describes serious or life- threatening circumstances to stay away from while using the device, their consequences, and how to avoid danger.

4. Precaution Special steps you need to take while using the device preventing minor or moderate injury to either you or the device.

Indications for use

Investigational device. Limited by Federal (or United States) law to investigational use only. If a medical emergency occurs, please contact 911.

4 Contraindication

No MRI/CT/Diathermy - MR Unsafe

Don’t wear your Bios device (sensor, transmitter, receiver, or smart device) for magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.

The Bios device hasn’t been tested in those situations. The magnetic fields and heat could damage the components of the Bios device, which may cause it to display inaccurate Bios sensor glucose readings (Bios device readings) or may prevent alerts.

Warnings

Read user manual

Before you use the Bios device, please read all associated materials or you will not use it correctly.

Don’t ignore high/low symptoms

The Bios device will not indicate any information regarding your glucose levels. Please use approved devices to make decisions. Use your blood glucose meter (SMBG) to make diabetes treatment decisions or, if needed, seek immediate medical attention.

Don’t use if…

Do not use the Bios device if you are pregnant, on dialysis, or critically ill.

Avoid contact with broken skin

Do not wear the Bios device on top of broken skin. If irritation or reaction occurs, immediately contact your health care professional.

5 Inspect

Don’t use a damaged or cracked Bios device transmitter. A damaged Bios device transmitter could cause injuries from electrical shocks and may make the Bios device not work correctly.

Use as directed

The Bios transmitter and sensor is small and may pose a choking hazard. Don’t put it in your mouth or let children hold it without adult supervision.

Check settings

Notifications: When using your smart device, you should confirm that your volume is turned up, your phone is not muted, and you do not have headphones plugged in. If your volume is not turned up, the device is muted, or headphones are plugged in, you will not hear the sound of any notifications, including important alarms.

Bluetooth: Your Bios transmitter talks to your app via Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information.

Battery: The GraphWear patient application must always be running in the background and may drain your smart device battery. Keep the battery charged.

Where to wear All patients will be required to wear Bios devices on 3 different locations: right wrist (RW) seen at location 1, left wrist (LW) seen at location 2, and lower abdomen (LA) seen at location 3.

Precaution

Avoid sunscreen and insect repellant

Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your Bios device crack. Before using your Bios device, make sure there are no cracks in your transmitter. If you find a crack, please contact Technical Support. Do not allow these skin care products to contact your Bios device. After using skin care products, wash your hands before touching your Bios device. If any skin care products get on your Bios device, immediately wipe with a clean cloth.

Keep transmitter close to display

Keep your Bios transmitter and smart device within 20 ft with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate.

Is It On?

If the receiver or smart device is turned off (shut down), it will not show any alarm/alerts. Make sure your display device is turned on.

Keep dry

Make sure that the Bios device does not get wet. If liquid of any kind slides under the transmitter and onto the sensor, please remove the device from skin, remove the sensor, and let it dry for 30 minutes before rewearing.

Application needs to always remain open

Please ensure that your mobile application on your smart device is never closed. If it is closed, immediately reopen the application to ensure that the integrity of the data is maintained.

Device description

Purpose of device The purpose of the Bios device is to create a needle and pain free diabetic monitoring experience. The current version is for investigational use to ensure that the readings from the Bios device match currently used devices to ensure accuracy.

What’s in the box

The Bios device comes with two boxes. The boxes contain the following

BIOS DEVICES COMPONENTS # Provided

Transmitter x 3

Charger x 3

Charging cable x 3

Wall charger x 1

Sensor x 9

Band x 2 Pre-attached to transmitter

Patches x 4

COMMERCIALLY AVAILABLE ACCESSORIES # Provided

Self Monitoring Blood x 1 Glucose (SMBG) meter kit

Self Monitoring Blood Glucose (SMBG) strips x 1

Self Monitoring Blood Glucose (SMBG) lancets

x 1

Transmitter: The transmitter houses the replaceable sensor and sends the glucose information to the application on the smartphone. Device charger: The charger is used to charge the transmitter battery. For best results, recharge the transmitter between each use to ensure full transmitter battery life. Charging cable: The charging cable is used to plug the transmitter into the provided wall charger. Wall charger: The wall charger is used to plug the chargers into a wall outlet to charge all three devices at once. Sensor: The sensor measures glucose and conveys that information to the transmitter Band: Holds the transmitter with inserted sensor in place when worn as a watch on the wrist. Patch: Holds the transmitter with inserted sensor in place when worn on-body (e.g., abdomen). Self Monitoring Blood Glucose (SMBG) meter: Provided for subject convenience to use during the trial Self Monitoring Blood Glucose (SMBG) strips: Provided for subject convenience to use during the trial.

Operating information

Minimum smart device specifications

To use the Bios device, you need a smart device that meets the following specifications. You will find a comprehensive list of almost all compliant devices below.

Smart device must have at least 100MB free space throughout the course of the trial.

Smart device must have access to an internet connection, either WiFi or mobile data (2G, 3G, LTE, etc), at least once every 3 hours throughout the course of the trial.

Smart device must not change throughout the course of the trial.

Android Software requirements Android 5.0 or greater Should not be rooted

11 Hardware requirements Camera Wifi and Internet Touchscreen Bluetooth: BLE v4.2 or greater RAM: 128MB

iOS Software requirements iOS 11.4 or greater Should not be jailbroken Hardware requirements Camera Wifi and Internet Touchscreen Bluetooth: BLE v4.2 or greater RAM: 128MB

Installing the app

To start using your Bios device, the first step is to install the mobile application on your smart device.

For iOS

12 1. Make sure you have internet access on your phone. Open the “App Store” on your smart device by clicking the icon, as shown.

13 2. Select the “Search” tab on the bottom right of the screen. Next, select the search bar at the top of the screen.

14 3. Type “GraphWear” into the search bar and click on “Search”.

15 4. Click on the “Get” button and follow the on screen instructions to download the GraphWear app.

16 5. Once the application is installed, click on “Open”.

17 6. You will be asked to give permission for the app to allow access to your camera so you can take images using the app. Click “OK”.

18 7. You will be asked to give permission for the app to push notifications to your smart device. Click “Allow”.

19 8. Scan the QR code given to you by your clinician. This will automatically log you into the GraphWear app. Please ensure that you have network access before or during this step, either via WiFi or mobile data.

20 9. You are now ready to set up your devices. Please ensure your Bluetooth is ON. You will see a status message on the home page of your app to connect to your devices. You are now ready to set up your Bios devices.

21 For Android

1. Make sure you have internet access on your phone. Open the “Play Store” on your smart device by clicking the correct icon, as shown.

22 2. Select the “Search” box at the top of the screen.

23 3. Type “GraphWear” into the search bar and click on “Search”.

24 4. Click on the GraphWear app, which is the top one in the list shown.

25 5. Click the “Install” button to install the GraphWear app.

26 6. Click the “Open” button to go ahead and open the GraphWear app.

27 7. You will be asked to give permission for the app to allow access to your camera so you can take images using the app. Click “OK”.

28 8. Scan the QR code given to you by your clinician using the GraphWear app. This will automatically log you into the GraphWear app. Please ensure that you have network access before or during this step, either via WiFi or mobile data.

29 9. You will be asked to give permission for the app to allow access to the device’s location, which is required for Bluetooth applications. Click “ALLOW”.

30 10. You are now ready to set up your devices. You may be asked to turn Bluetooth ON. You will see a status message on the home page of your app to connect to your devices. You are now ready to set up your Bios devices.

31 Setting up Bios devices Now that the mobile application is ready, it is time to prepare to wear the Bios devices. Each package contains 3 transmitters, to be worn on the left wrist (LW), the right wrist (RW), and the lower abdomen (LA).

Setting up Left Wrist (LW) device

1. Open the GraphWear mobile application: Open the GraphWear application that you already installed on your phone. On the home page, you will see a flashing red Bluetooth icon labelled LW, which indicates your device isn’t connected. Let’s set up your Bios device so we can connect it to your phone.

2. Remove device from box: Take out the leftmost transmitter labelled “LW” (circled in green) from your giftbox.

3. Check if sensor is pre-loaded: The LW transmitter has already been pre-loaded with a replaceable glucose sensor and a wearable band. In the event the transmitter is not preloaded with the sensor, follow step 4 and 5 to insert a new sensor. Otherwise, proceed to step 6 to turn your device ON.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

4. Scan the sensor: Pull out the first available sensor from your giftbox in order from left to right, starting from Set 1 Sensor 1. Click on the flashing red LW Bluetooth icon on the top left corner of the GraphWear mobile application. Scan the QR code on the back of your sensor.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

Android iOS

If scanning doesn’t work, you can also enter the numeric code manually. Click on ‘Enter code manually’, type in the code and click on ‘Submit’.

Android iOS

You are now ready to insert the sensor.

5. Insert the sensor: In turning over the transmitter, you should see a cavity that is identical in shape to the sensor. Making sure the notch on the right side of the sensor is

35 aligned to the notch on the transmitter, place the top edge of the sensor into the transmitter and lower the sensor into place. It should snap into place magnetically.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

Press the “G” touch button gently for one second. If the screen reads “Reinsert”, ensure that the sensor is snug against the transmitter.

36 Ensure that the sensor is snug against the transmitter by pressing on the bottom of the sensor gently. If the screen still reads “Reinsert”, please repeat step 4 to replace with a new sensor.

Once you have inserted the sensor, the device automatically turns ON and the status message on the screen of your device will read “Wear device”. To view the status message again, you can press the “G” touch button gently for one second. If the device shows “Wear device”, proceed to Step 7.

37 6. Turn device ON: If the sensor is inserted and the device is OFF, press the “G” touch button gently for 3 seconds. Your device will turn ON and a blue LED light will glow on the top right corner of the device. A “Welcome” message will flash on the device screen. This will be followed by the message “Wear device”.

In case the sensor isn’t inserted in the device, the screen will read “Insert sensor”. Follow step 5 to insert the sensor. You can view the status message again by pressing the “G” touch button gently for one second. If it reads “Wear device”, proceed to step 7.

38 7. Wear device: Making sure your palm is facing up, place the transmitter on the inside of your left arm.

Cinch the watch strap, as shown below.

39 Insert excess watch strap into the strap loop, adjusting for comfort. Please ensure that device is snug against the skin, but not so tight that it will interfere with blood flow or cause discomfort.

When you press the “G” touch button gently for 1 second, the status message on the device screen should read “Connect to phone”.

40 8. Connect to phone: Once you have worn the device, a prompt will appear in the GraphWear mobile application to enter a passkey. Check the screen of your LW device for the passkey and enter it into the app.

You will see the flashing red Bluetooth icon labelled LW in the top left corner of the app turn green. Press gently on the “G” logo touch button for 1 second, the status message on the device screen should read “Connected”.

Congratulations! Your left wrist device setup is now complete. Enjoy using your Bios device.

41 Setting up Right Wrist (RW) device

1. Open the GraphWear mobile application: Open the GraphWear application that you already installed on your phone. On the home page, you will see a flashing red Bluetooth icon labelled RW, which indicates your device isn’t connected. Let’s set up your Bios device so we can connect it to your phone.

2. Remove device from box: Take out the right most transmitter labelled “RW” (circled in green) from your giftbox.

3. Check if sensor is pre-loaded: The RW transmitter has already been pre-loaded with a replaceable glucose sensor and a wearable band. In the event the transmitter is not preloaded with the sensor, follow step 4 and 5 to insert a new sensor. Otherwise, proceed to step 6 to turn your device ON.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

43 4. Scan the sensor: Pull out the first available sensor from your giftbox in order from left to right, starting from Set 1 Sensor 1. Click on the flashing red RW Bluetooth icon on the top center of the GraphWear mobile application. Scan the QR code on the back of your sensor.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

Android iOS

44 If scanning doesn’t work, you can also enter the numeric code manually. Click on ‘Enter code manually’, type in the code and click on ‘Submit’.

Android iOS

You are now ready to insert the sensor.

45 5. Insert the sensor: In turning over the transmitter, you should see a cavity that is identical in shape to the sensor. Making sure the notch on the right side of the sensor is aligned to the notch on the transmitter, place the top edge of the sensor into the transmitter and lower the sensor into place. It should snap into place magnetically.

CAUTION: Do not scratch, peel, or damage the surface of the sensor.

Press the “G” touch button gently for one second, if the screen reads “Reinsert”, ensure that the sensor is snug against the transmitter

46 Ensure that the sensor is snug against the transmitter by pressing on the bottom of the sensor gently. If the screen still reads “Reinsert”, please repeat step 4 to replace with a new sensor.

47 6. Turn device ON: If the sensor is inserted and the device is OFF, press the “G” touch button gently for 3 seconds. Your device will turn ON and a blue LED light will glow on the top right corner of the device. A “Welcome” message will flash on the device screen. This will be followed by the message “Wear device”.

48 7. Wear device: Making sure your palm is facing up, place the transmitter on the inside of your right arm.

Cinch the watch strap, as shown below.

49 Insert excess watch strap into the strap loop, adjusting for comfort. Please ensure that device is snug against the skin, but not so tight that it will interfere with blood flow or cause discomfort.

When you press the “G” touch button gently for 1 second, the status message on the device screen should read “Connect to phone”.

50 8. Connect to phone: Once you have worn the device, a prompt will appear in the GraphWear mobile application to enter a passkey. Check the screen of your RW device for the passkey and enter it into the app.

You will see the flashing red Bluetooth icon labelled RW in the top center of the app turn green. Press gently on the “G” logo touch button for 1 second, the status message on the device screen should read “Connected”.

51 Congratulations! Your right wrist device setup is now complete. Enjoy using your Bios device.

Setting up Lower Abdomen (LA) device

Locate and wear patch on skin

1. Locate the patch box in the bottom most layer of the box. Pull out a new pre-packaged patch from the box.

52 2. Open the patch from its packaging and remove the adhesive protective layer.

3. Apply the adhesive side of the patch to the lower abdomen, about 10 cm left or right of the belly button, as shown in the image below. Apply the patch gently so that one edge first touches the skin.

53 After the edge of the patch is stuck firmly on the skin, apply even pressure across the patch, ensuring minimal air gaps underneath.

You are now ready to set up your LA device.

54 Device setup

1. Open the GraphWear mobile application: Open the GraphWear application that you already installed on your phone. On the home page, you will see a flashing red Bluetooth icon labelled LA, which indicates your device isn’t connected. Let’s set up your Bios device so we can connect it to your phone.

2. Remove device from box: Take out the middle transmitter labelled “LA” (circled in green) from your giftbox.

55 3. Check if sensor is pre-loaded: The LA transmitter has already been pre-loaded with a replaceable glucose sensor and a wearable band. In the event the transmitter is not preloaded with the sensor, follow step 4 and 5 to insert a new sensor. Otherwise, proceed to step 6 to turn your device ON.

56 4. Scan the sensor: Pull out the first available sensor from your giftbox in order from left to right, starting from Set 1 Sensor 1. Click on the flashing red LA Bluetooth icon on the top right corner of the GraphWear mobile application. Scan the QR code on the back of your sensor.

Android iOS

57 If scanning doesn’t work, you can also enter the numeric code manually. Click on ‘Enter code manually’, type in the code and click on ‘Submit’.

Android iOS

You are now ready to insert the sensor.

58 5. Insert the sensor: In turning over the transmitter, you should see a cavity that is identical in shape to the sensor. Making sure the notch on the right side of the sensor is aligned to the notch on the transmitter, place the top edge of the sensor into the transmitter and lower the sensor into place. It should snap into place magnetically.

Press the “G” touch button gently for one second, if the screen reads “Reinsert”, ensure that the sensor is snug against the transmitter.

59 Ensure that the sensor is snug against the transmitter by pressing on the bottom of the sensor gently. If the screen still reads “Reinsert”, please repeat step 4 to replace with a new sensor.

6. Turn device ON: If the sensor is inserted and the device is OFF, press the “G” touch button gently for 3 seconds. Your device will turn ON and a blue LED light will glow on the top right corner of the device. A “Welcome” message will flash on the device screen. This will be followed by the message “Wear device”.

7. Connect to phone: Once you have inserted the sensor, the device screen will show ‘Wear device’. Wait up to 2 minutes and a prompt will appear in the GraphWear mobile application to enter a passkey. Check the screen of your LA device for the passkey and enter it into the app.

61 You will see the flashing red Bluetooth icon labelled LA in the top right corner of the app turn green. Press gently on the “G” logo touch button for 1 second, the status message on the device screen should read “Wear device”.

8. Insert device into the patch frame: Ensuring that the logo is facing out, insert the device into the plastic cavity within the patch. To do this, put one corner of the device into the aligned corner of the plastic cavity.

Gently apply pressure using your fingers until the device clicks into the patch frame.

Press the “G” logo touch button gently for 1 second. The status message on the device screen should read “Connected”.

63 Confirming that all devices are connected

Now that you’ve set up all your Bios devices and have begun collecting data. Check your smart device periodically to ensure that the home page shows a thumbs up icon.

Android iOS

In case any of the Bluetooth icons above each device (LW, RW, LA) is red, please wait for 2 minutes. If after 2 minutes you don’t see the thumbs up icon, please restart the app and try again until the home page shows a thumbs up icon.

64 Removing the devices

Wrist devices: To remove the Left Wrist (LW) and Right Wrist (RW) devices, pull the watch strap out of the strap loop and pull up, ensuring the pin comes out of the pin holes in the watch strap.

You can now safely remove the device, by pulling on the shorter end of the band.

65 Abdomen device: To remove the Lower Abdomen (LA) transmitter, hold the device, twist counterclockwise and lift up slowly. The corner of the device should come away from the plastic cavity in the patch.

You can now remove the transmitter, by gently pulling it away from the patch.

66 CAUTION: When you remove your devices for any reason please make sure the devices are always placed screen face down so that the sensors are always face up and never in contact with any surface to avoid damage.

Removing the sensors

To remove the sensor, hold the device with the screen facing down. Find the cavity at the bottom of the sensor

Pull up gently using a fingernail.

67 The sensor should separate from the transmitter.

CAUTION: When you remove your sensor from the device, please make sure to place the sensors face up on the magnetic sheet provided inside the gift box (except when you change the sensor). Make sure to keep the sensors associated with each transmitter on the appropriate labelled section on the magnetic sheet. Ensure that the sensors are inserted into the correct transmitters when inserting back onto the transmitters.

68 How to charge the transmitter

Your transmitter will need to be charged once every 24 hours. You will be notified when to charge the transmitter via your smart device. When a device (LW, RW, LA) needs to be charged a red flashing low battery icon will appear for that device on the home page of your GraphWear app.

Android iOS

69 In addition, the transmitter light will be blinking red and the screen on the transmitter will read “Charge now”

71 To charge the transmitters, follow the instructions below.

1. Remove the chargers, cables and wall adapter: For convenience, you have been provided with 3 chargers, 3 cables, and a wall adapter to charge each transmitter simultaneously. Remove the 3 USB charging cables (one for each of the 3 chargers) provided in the giftbox.

72 2. Plug USB cable(s) into charger: Plug the USB-C end of the USB cable into the provided port in all the 3 chargers.

3. Plug charger(s) into the wall adapter: Insert the USB A ends of the USB cables into the ports of the 3-1 wall charging adapter. Plug the adapter into a power source to begin charging. You can charge all the 3 transmitters simultaneously

4. Remove devices from skin: Follow the instructions in the “Removing the devices” section above.

73 5. Remove the sensors from the transmitter: Follow the instructions in the “Removing the sensors” section above. Make sure there is no sensor in your transmitter before charging.

6. Keep sensors safe during charge: Each box is provided with a magnetic sheet with labels LW, RW and LA for storing sensors safely during charging. Remove the sensors from the transmitter while charging and gently place them face up on the respective slots on the magnetic sheet provided inside of your giftbox.

CAUTION: Make sure to keep the sensors associated with each transmitter on the appropriate labelled section on the magnetic sheet. Ensure that the sensors are inserted back into the correct transmitters after charging.

74 7. Place transmitter(s) into the charger: Ensuring that the sensor is removed, place the transmitter on the charger, aligning the transmitter’s edges with the cavity within the charger.

It will automatically snap in and screen will display “Charging”. The transmitter light will be solid red.

Charging of your transmitter will take about 2.5 hours.

CAUTION: All of your transmitters need to be charged simultaneously to ensure that data is collected at the same time.

76 8. Complete charging: When the transmitter is fully charged, the transmitter display screen will read “Charged” and the transmitter light will turn green.

77 9. Remove transmitters from charger and insert back sensors: Once the transmitters are charged, insert the sensors back into the transmitters. Please ensure that the sensors placed above the labels on the magnetic sheet are inserted into the transmitters with the same labels (LW, RW, LA)

10. Wear your devices: Wear your three devices once more following the instructions provided in the “Setting up Bios device” sections above.

Setting up and using your Self Monitoring Blood Glucose (SMBG) meter

As part of your trial, you will be required to provide 7 or more SMBG meter readings daily, each spaced a minimum of 1 hour apart. A SMBG meter has been provided to you as part of your package. Please read and follow the instructions of the SMBG meter as required to ensure accurate collection of values.

78 The recommended times to collect SMBG values are as below:

● First thing upon waking ● Before and after any meal ● Before sleeping

While using the SMBG, please use the SMBG strip boxes in the labelled order. Start with box 1, then box 2, and finally box 3.

Inserting blood values into the application

Once you have collected a SMBG meter value, you should immediately insert the value into the mobile application on your smart device. To do this, follow the instructions below.

1. Open GraphWear application: Click on the GraphWear app icon on your smart device. The mobile application should be running at all times in the background.

Android

79 iOS

80 2. Click on the SMBG icon: Click on the SMBG icon at the bottom center of the home page of your GraphWear application. This will open a dialogue box to enter the blood value.

Android iOS

81 3. Input the blood value: In the dialogue box, click on the box with the units mg/dl. An input keypad will open upon clicking. Type in the value you see on your SMBG meter and hit the “Submit” button on the screen.

Android iOS

82 4. Take a picture of your SMBG: Upon hitting the submit button, your camera will automatically open up. Please take an image of the SMBG meter value.

Android iOS

83 Once you take the image, it will show “Uploading image” and then revert to your home page.

Android iOS

84 Inserting meal and exercise information

1. Open GraphWear application: Click on the GraphWear app icon on your smart device. The mobile application should always be running in the background.

Android iOS

85 2. Click on the meal icon: Click on the meal icon at the bottom right of the home page of your GraphWear application. This will open a dialogue box to enter the meal or exercise.

Android iOS

86 3. Select the meal type or exercise: On the pop up screen, select the meal type or exercise. Click on the box labelled “description”, a keypad will open up. Use the keypad to enter the description in the box. After you have entered the information, click on the “Submit” button.

Android

87 iOS

88 Inserting medication information

1. Open GraphWear application: Click on the GraphWear app icon on your smart device. The mobile application should be running at all times in the background.

Android iOS

89 2. Click on the medication icon: On the bottom left corner of the home page of the GraphWear application, click on the medication icon. A dialogue box will open up.

Android iOS

90 3. Select the medication: In the dialogue box, select the medication type. When you click on the name or quantity box that appear underneath, a keypad will open up. Use the keypad to enter the name and dosage quantity. After you have entered the information, click on the “Submit” button.

Android iOS

91 Change sensor

In the event there is something wrong with the sensor you will need to replace the sensor with a new one. A “Change sensor!” notification will appear on your smart device. You won’t be able to continue using the device until you change the sensor. Follow the instructions below to change your sensor.

1. Open GraphWear application: Click on the GraphWear app icon on your smart device. The mobile application should always be running in the background.

Android iOS

92 2. Check prompt to know which sensor to replace: You will see a pop up screen on the home page of the GraphWear application with a prompt to change the sensor in one of your devices: either LW, RW or LA device sensor.

Android iOS

3. Remove the sensor from the device: Follow the instructions provided in “Removing the sensors” in the “Setting up Bios devices” section above to remove the sensor from the device as detailed on the prompt.

93 4. Store the removed sensor: Locate the ziplock bag in the patch box in the gift box provided to you.

Place the sensor you just removed from the device in the ziplock bag.

Keep the ziplock bag safely back in the patch box for future use.

5. Pull out a new sensor from giftbox: Pull out the first available sensor from your giftbox in order from left to right, starting from Set 1 Sensor 1.

95 6. Scan the sensor: On the GraphWear app, click on “Scan sensor code”. Your smart device camera will open to scan the sensor. Locate the QR code on the back of the sensor and scan it.

Android iOS

96 7. If the scan doesn't work, click on “Enter manually” and type in the code provided on the back of the sensor. Click on “Submit”.

Android iOS

8. Insert the new sensor: Follow the instructions provided in “Insert the sensor” in the “Setting up Bios devices” section above.

9. Wear the device: Follow the instructions provided in “Wear device” in the “Setting up Bios devices” section above to wear your device again.

97 Providing feedback

1. Open GraphWear application: Click on the GraphWear app icon on your smart device. The mobile application should be running at all times in the background.

Android iOS

98 2. Click on the “?” icon: On the top right corner of the home page of the GraphWear application, click on the “?” icon. A dialogue box will open up.

Android iOS

99 3. Insert and submit feedback: In the dialogue box, click on the box labelled “Description”. An input keypad will open upon clicking. Type in the feedback description and click on the submit button.

Android iOS

100 Troubleshooting information

What messages on your transmitter display mean

Your GraphWear transmitter comes equipped with a display. For more information regarding various messages you can see on the display, refer to the table below.

Screen text Meaning

Insert sensor There is no sensor in the device or the sensor is not being detected by the device. Please ensure that the sensor is aligned with the notch on the back of the device. After the sensor has been inserted, the transmitter screen should show “Wear device”

Wear device The device has not detected contact with skin* to ensure it is being worn. If worn and you see this message, please readjust your band until this message is no longer visible.

*This message is only visible if the sensor has been inserted and detected

Connect to phone The device is disconnected from the mobile application. Please ensure your application is open on your smart device.*

*This message is only visible if the sensor is inserted and detected, and the device has been worn and is detecting skin contact

Reinsert The sensor is not inserted snugly against the device. Press gently on the bottom of the sensor to ensure it is snug against the device, following the “insert the sensor” steps

Connected The device is connected to your smart device and data collection is in progress

Open indicate The device is experiencing difficulties pairing with your smart device. Please follow the instructions in the FAQ section, “My transmitter shows open indicate”

Charge now The device battery is low on charge. Please charge the device using the instructions in

101 “How to charge the transmitter”.

Charging The device is charging, please wait until the message on the display changes to “Charged” before using the devices.

Charged The device is now fully charged. You can start wearing it again, following the instructions detailed in the “Setting up device” steps.

Del. OK. Pl. reboot You properly deleted the pairing information from your device. To use the device, follow the instructions in the corresponding “Setting up device” steps. You will have to pair your devices again

Data uploading The transmitter stores data when not connected to the phone for up to 6 hours. As soon as the device is connected to your phone, the transmitter uploads the stored data and displays ‘Data uploading’

Shutting down The device is shutting down. You will need to turn it back ON to use it.

Passkey: “xxxxxx“ To pair the device with your phone, the device screen displays a passkey. Enter the passkey into the GraphWear mobile application to pair the device

FAQ?

I need to access the FAQ from my app

To access the FAQ from your mobile app, please click on the “?” icon on the top right of the GraphWear home page. You will see a “Go to FAQ” button, click on that to go to FAQ. You will be redirected to our website.

I am unable to install the mobile application on my smart device. What should I do?

● Ensure that you followed all the instructions in the user manual ● Ensure that your smart device meets the requirements in Appendix A

102 ● Ensure that you have a working internet connection ● If problems persist, please inform your physician

My transmitter is not ON

● Check whether the transmitter is ON by pressing the “G” touch button gently for one second. If the transmitter is on, the screen should light up and show a message ● If the transmitter is not ON, ensure that the sensor is firmly placed within the cavity ● Press the “G” touch button gently for three seconds. This should turn the device ON ● Follow instructions for charging the transmitter to ensure the device is fully charged ● If your transmitter continues to stay off, please inform your physician

My transmitter will not connect

● Ensure that the transmitter is ON ● Ensure that the app is open and running without any error messages ● Wait up to 2 minutes to allow the connection to take place ● Restart the mobile app and try again ● If your transmitter continues to remain disconnected, please inform your physician

My app notified me that my transmitter has disconnected

● Ensure that the transmitter is ON. If it is not ON, press the “G” touch button gently for three seconds. This should turn the device ON ● Check the app to see the connection status of the transmitter. If there is a disconnection, the transmitter should automatically reconnect within 2 minutes. If it doesn’t reconnect, restart your app and turn your device ON. ● Ensure that your smart device remains within 20 feet with no obstacles from your transmitters. ● If the app continues to notify you of disconnection, please inform your physician

My transmitter shows ‘Data uploading’

● The transmitter stores a certain amount of data when the phone is not connected ● As soon as the phone is connected, the transmitter uploads the stored data and displays ‘Data uploading’ ● Once all the data is uploaded the transmitter while show ‘connected’

103 My transmitter shows ‘Open indicate’

● Wait for a few seconds and the transmitter will connect to the mobile application; ● If it continues to show ‘Open indicate’ on the transmitter, close and restart the mobile application and wait for 2 minutes; ● If it still continues to show ‘Open indicate’ on the transmitter, please inform your physician

What if I lost my phone?

● First, inform your physician immediately. Your physician will communicate with the GraphWear team to inform them of the situation. ● Once the physician gives the go ahead to start on your new phone, install the mobile application by following steps for ‘Installing the app’. ● Turn the device ON by following steps to ‘Insert the sensor’ in ‘Setting up Bios device’ section ● Once the transmitter is turned ON, remove the sensor from the transmitter by following the steps for ‘Removing the sensors’ ● Once the transmitter shows ‘Insert sensor’ hold the device flush against your palm with the screen side up and press the ‘G logo’ gently for 5 seconds. The transmitter will show ‘Del. OK PL. reboot’ and the transmitter will shutdown ● Next follow steps to turn ON and set up device in ‘Setting up Bios device’ section

My device keeps on showing ‘re-insert’ while I am wearing

Please continue wearing your device, until you receive further instructions on the GraphWear application or from your physician.

My phone ran out of battery

● Your Bios device stores data on a local memory chip for up to 6 hours. Please ensure you charge your phone and get connected within this time. ● If your phone is going to be out of charge for over 6 hours, please contact your physician and let them know.

What is the QR code on the top left of my app? The QR code on the top left of the application is your personal identifier. It allows your physician to keep track of your progress throughout the course of the trial. Clicking on it will enlarge it, allowing your physician to scan it.

104 What is the “?” on the top right of my app? Clicking on the “?” will allow you to be provide anonymous feedback to the GraphWear team

On my Android phone, when I click “Capture”, the app doesn’t take a picture of my SMBG

When you click on “Capture” while taking a picture of your SMBG, if the app does not take a picture, click the back button of your smart device. This will take you back to the “Insert blood value” screen. Please reinsert the blood value and try again.

When I wear my devices again and try to connect, the device screen shows a six digit passkey

In the event your phone accidentally deletes the pairing information, the device will try to pair with the phone again. If this happens, the device screen will show a six digit pass key within 2 minutes after it is turned ON. Enter the passkey shown on the device screen into the GraphWear app to connect to the phone.

User assistance information

For any help or support inquiries, please contact your physician.

105 Appendix

Appendix A - Compatible smart devices

Android devices

Samsung Galaxy A50 Samsung Galaxy A70 Samsung Galaxy A30 Samsung Galaxy A80 Samsung Galaxy A20 Samsung Galaxy A10 Samsung Galaxy S10+ Samsung Galaxy M40 Samsung Galaxy S10 Samsung Galaxy S8 Samsung Galaxy M20 Samsung Galaxy Note9 Samsung Galaxy S10e Samsung Galaxy M30 Samsung Galaxy Note10+ Samsung Galaxy A40 Samsung Galaxy S7 edge Samsung Galaxy A7 (2018) Samsung Galaxy S10 5G Samsung Galaxy S7 Samsung Galaxy S9 Samsung Galaxy M10 Samsung Galaxy A60 Samsung Galaxy S9+ Samsung Galaxy A9 (2018) Samsung Galaxy Note8 Samsung Galaxy A2 Core Samsung Galaxy S8+ Samsung Galaxy Note5 Samsung Galaxy A20e Samsung Galaxy A8 (2018) Samsung Galaxy J6+ Samsung Galaxy Fold Samsung Galaxy J4+

106 Samsung Galaxy J6 Samsung Galaxy J5 Prime Samsung Galaxy Xcover 4s Samsung Galaxy J8 Samsung Galaxy A7 (2017) Samsung Galaxy A5 (2017) Samsung Galaxy A6+ (2018) Samsung Galaxy A6 (2018) Samsung Galaxy J2 Prime Samsung Galaxy J2 Core Samsung Galaxy A8s Samsung Galaxy C9 Pro Samsung Galaxy Grand Prime Plus Samsung Galaxy A8+ (2018) Samsung Galaxy J2 Pro (2018) Samsung Galaxy J4 Core Samsung Galaxy J4 Samsung Galaxy A8 Star (A9 Star) Samsung Galaxy S6 edge+ Samsung Galaxy A3 (2017) Samsung Galaxy Note7 Samsung Galaxy J3 (2018) Samsung Galaxy C5 Samsung Galaxy J7 (2018) Samsung Galaxy A9 Pro (2016) Samsung Galaxy J3 (2017) Samsung Galaxy Note FE Samsung Galaxy C7 Samsung Galaxy A6s Samsung Galaxy J7 Max Samsung Galaxy J7 Duo Samsung Galaxy C7 Pro Samsung Galaxy S Light Luxury Samsung Galaxy Xcover 4 Samsung Galaxy S7 active Samsung Galaxy Folder2 T-Mobile Revvlry+ T-Mobile Revvlry T-Mobile Revvl ZTE nubia Red Magic 3

107 ZTE Axon 10 Pro ZTE Axon 10 Pro 5G ZTE nubia X 5G ZTE nubia X ZTE Blade A5 (2019) ZTE nubia Red Magic Mars ZTE Axon 7 ZTE nubia Red Magic ZTE Blade V10 ZTE Blade Z Max ZTE nubia Z18 ZTE Axon 9 Pro ZTE Blade V10 Vita ZTE Blade A3 (2019) ZTE Blade L8 ZTE Blade A7 ZTE Axon M ZTE nubia Z18 mini ZTE Blade V9 Vita ZTE nubia Z17 lite ZTE Blade V9 ZTE Blade A7 Vita ZTE Max XL ZTE Blade Force ZTE Blade X ZTE Grand X4 ZTE Axon 7s ZTE Tempo Go ZTE Blade V8 Pro ZTE Axon 7 Max Xiaomi Redmi Note 7 Xiaomi Redmi K20 Pro Xiaomi Mi 9T Xiaomi Mi CC9 Xiaomi Redmi Note 7 Pro Xiaomi Mi CC9e Xiaomi Redmi K20 Xiaomi Mi 9 Xiaomi Redmi 7 Xiaomi Pocophone F1

108 Xiaomi Redmi 7A Xiaomi Mi 9 SE Xiaomi Mi A2 (Mi 6X) Xiaomi Mi A2 Lite (Redmi 6 Pro) Xiaomi Black Shark 2 Xiaomi Mi 8 Lite Xiaomi Mi A3 Xiaomi Redmi Note 7S Xiaomi Redmi Note 6 Pro Xiaomi Redmi 6A Xiaomi Mi 8 Xiaomi Redmi Note 5 Pro Xiaomi Redmi 6 Xiaomi Redmi Y3 Xiaomi Mi Play Xiaomi Mi Mix 3 Xiaomi Mi A1 (Mi 5X) Xiaomi Redmi 5 Plus (Redmi Note 5) Xiaomi Mi Max 3 Xiaomi Redmi 4 (4X) Xiaomi Mi 5 Xiaomi Mi 8 Pro Xiaomi Redmi S2 (Redmi Y2) Xiaomi Mi 9 Explorer Xiaomi Mi Mix 3 5G Xiaomi Redmi 5 Xiaomi Mi Note 3 Xiaomi Redmi Note 5 AI Dual Camera Xiaomi Redmi Note 4X Xiaomi Mi Max Xiaomi Black Shark Xiaomi Mi Mix 2S Xiaomi Mi 8 SE Xiaomi Mi 6 Xiaomi Mi Max 2 Xiaomi Mi Mix 2 Xiaomi Mi Mix Xiaomi Redmi Y1 (Note 5A) Xiaomi Mi Note 2 Xiaomi Black Shark Helo

109 Xiaomi Redmi 4 Prime Xiaomi Redmi Pro 2 Xiaomi Mi 5s Xiaomi Mi 9X Xiaomi Redmi Pro Xiaomi Redmi Note 4 (MediaTek) Xiaomi Mi 8 Explorer Xiaomi Mi 5s Plus Xiaomi Redmi Y1 Lite Sony Xperia 1 Sony Xperia XZ Sony Xperia 10 Plus Sony Xperia X Performance Sony Xperia XZ3 Sony Xperia 10 Sony Xperia X Compact Sony Xperia XZ1 Sony Xperia XZ Premium Sony Xperia XZ2 Sony Xperia L3 Sony Xperia XZ2 Compact Sony Xperia X Sony Xperia XA2 Sony Xperia XA1 Sony Xperia XZ1 Compact Sony Xperia XZ2 Premium Sony Xperia XA2 Ultra Sony Xperia XZs Sony Xperia XA2 Plus Sony Xperia XA1 Ultra Sony Xperia L1 Sony Xperia XA1 Plus Sony Xperia L2 Sony Xperia R1 (Plus) OnePlus 7 Pro Oppo F11 Pro Oppo Reno 10x zoom OnePlus 7 Oppo K3 Oppo A5s (AX5s)

110 Oppo F11 Oppo A3s Oppo Reno OnePlus 6T Oppo Reno Z OnePlus 6 Oppo F9 (F9 Pro) Oppo A7 OnePlus 7 Pro 5G Oppo A1k Oppo F7 Oppo Find X Oppo Reno 5G OnePlus 5T Oppo F5 OnePlus 3 OnePlus 5 Oppo A9 Razer Phone 2 OnePlus 3T Oppo A83 Oppo A9x Oppo RX17 Pro Oppo A5 (AX5) Oppo R17 OnePlus 6T McLaren Oppo K1 Oppo A7n Oppo R15 Pro Sharp Aquos Zero Oppo A3 Oppo F5 Youth Razer Phone Sharp Aquos R2 compact Oppo A71 (2018) Oppo A7x Oppo RX17 Neo Panasonic Eluga I7 (2019) Oppo R15x Oppo R15

111 Oppo F7 Youth Oppo A1 Oppo R11 Sharp Aquos C10 Sharp Aquos S3 Oppo R11s Sharp Aquos S2 Panasonic Eluga X1 Pro Panasonic Eluga Z1 Pro Oppo A77 Oppo R11s Plus Sharp Aquos R2 Sharp Aquos S3 High Panasonic Eluga Ray 800 Oppo R11 Plus Sharp Aquos S3 mini Sharp R1S Nokia 9 PureView Nokia X71 Nokia 6.1 Plus (Nokia X6) Nokia 2.2 Motorola One Vision Nokia 4.2 Nokia 8.1 (Nokia X7) Nokia 7.1 Nokia 3.2 Nokia 7 plus Motorola Moto Z4 Motorola Moto G7 Power Nokia 6.1 Nokia 5.1 Plus (Nokia X5) Motorola Moto G7 Motorola Moto G7 Plus Nokia 3.1 C Nokia 8 Motorola Moto G6 Nokia 5.1 Nokia 3.1 Nokia 1 Plus Motorola One Power (P30 Note)

112 Motorola One (P30 Play) Nokia 2.1 Nokia 3.1 A Nokia 1 Nokia 8 Sirocco Motorola Moto G7 Play Nokia 8.1 Plus Motorola Moto X4 Motorola Moto G6 Plus Motorola One Pro Motorola Moto G5 Plus Motorola Moto E5 Plus Motorola Moto E5 Play Motorola Moto G6 Play Motorola Moto E5 Motorola Moto G5S Plus Motorola Moto Z3 Motorola Moto Z3 Play Motorola Razr 2019 Motorola Moto Z2 Play Motorola Moto E4 Plus Motorola Moto Z2 Force Motorola Moto G5 Motorola Moto E4 Motorola One Action Motorola Moto C Nokia 7 Motorola Moto G5S Motorola P40 Motorola P30 Motorola Moto C Plus Motorola Moto E6 Motorola Moto E5 Cruise Motorola Moto E5 Play Go LG W30 LG W30 Pro LG G6 LG V50 ThinQ 5G LG G8 ThinQ LG V30

113 LG G7 ThinQ LG G8S ThinQ LG W10 LG V20 LG G5 LG V40 ThinQ LG Stylo 5 LG Q60 LG Q6 LG V35 ThinQ LG Nexus 5X LG Q7 LG K40 LG Q Stylo 4 LG K8 LG G7 One LG V30S ThinQ LG G7 Fit LG K50 LG X power LG K11 Plus LG Q9 LG Q Stylus LG K8 (2018) LG Q8 LG K10 (2017) LG K30 LG G5 SE LG K20 plus LG Aristo 2 LG Stylo 3 Plus LG Tribute Empire LG K8 (2017) LG Stylus 2 Plus LG X power2 LG K10 (2018) LG X cam LG Q8 (2017) LG Harmony LG Candy

114 LG X venture LG Zone 4 LG X4+ LG X5 LG K7 (2017) LG X mach LG X max Lenovo Z6 Google Pixel 3a Google Pixel 3 Google Pixel 3a XL Google Pixel Google Pixel 3 XL Lenovo Z6 Pro Google Pixel XL HTC U19e Google Pixel 2 XL Google Pixel 2 Lenovo Z6 Pro 5G Lenovo Z6 Youth HTC Desire 19+ HTC 10 BlackBerry KEY2 LE HTC U12+ HTC U11 BlackBerry Evolve X BlackBerry KEY2 HTC Exodus 1 BlackBerry Keyone HTC Desire 10 Pro BlackBerry Evolve Lenovo Z5s HTC U12 life Lenovo S5 HTC U Ultra HTC Desire 12+ BlackBerry Motion Lenovo K6 Note Lenovo K5 Pro HTC U11+

115 Lenovo K8 Note HTC Desire 12s Lenovo K5 play Lenovo Z5 Pro Lenovo S5 Pro Lenovo Z5 Pro GT HTC Desire 12 Lenovo A5 Lenovo K6 Power Lenovo Z5 Lenovo K6 Enjoy HTC U Play BlackBerry DTEK60 BlackBerry DTEK50 Lenovo S5 Pro GT HTC U11 Life Lenovo K5 Note (2018) HTC One X9 Lenovo K8 Plus HTC U11 Eyes Lenovo K320t HTC One A9s Lenovo K8 HTC 10 Lifestyle Huawei P30 Pro Huawei P30 lite Huawei nova 5i Pro Huawei Y9 Prime (2019) Huawei P30 Huawei Y9 (2019) Huawei nova 5 Pro Huawei Mate 20 Pro Huawei nova 3i Huawei Y6 (2019) Huawei nova 5 Huawei Y5 (2019) Huawei P20 lite (2019) Huawei P20 Pro Huawei Y7 Prime (2019) Huawei nova 5i

116 Huawei P smart 2019 Huawei Mate 20 X (5G) Huawei P20 lite Huawei Mate 20 Huawei Mate 20 lite Huawei Mate 20 X Huawei Y7 Pro (2019) Huawei P20 Huawei Y6 Pro (2019) Huawei nova 4 Huawei P9 Huawei Y7 (2019) Huawei P Smart Z Huawei Mate 10 Pro Huawei nova 3 Huawei Y5 Prime (2018) Huawei Nexus 6P Huawei P10 Huawei Mate 10 Lite Huawei Y5 lite (2018) Huawei nova 4e Huawei Mate 9 Huawei P Smart+ 2019 Huawei P smart Huawei Mate X Huawei Y6 (2018) Huawei Mate 10 Huawei Y Max Huawei Y7 Prime (2018) Huawei P10 Plus Huawei Mate 8 Huawei P9 Plus Huawei Y9 (2018) Huawei Mate 9 Pro Huawei Mate 20 RS Porsche Design Huawei Enjoy 9s Huawei Enjoy 9e Huawei nova 2 Huawei Y7 (2018) Huawei Enjoy 9

117 Huawei Mate RS Porsche Design Huawei Y7 Pro (2018) Huawei Y6 Prime (2018) Huawei nova 2 plus Huawei Mate 10 Porsche Design Huawei nova 2s Huawei Mate 9 Porsche Design iOS devices iPhone XS iPhone XS Max iPhone XR iPhone X iPhone 8 iPhone 8 Plus iPhone 7 iPhone 7 Plus iPhone 6s iPhone 6s Plus iPhone 6 iPhone 6 Plus iPhone SE iPhone 5s

118